Form 483

Wayne State University Institutional Review Board Form 483, 2026-05-08

FDA issued a Form 483 to Wayne State University Institutional Review Board on 2026-05-08 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

Wayne State University Institutional Review Board · Detroit, United States · Issued May 8, 2026

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

8 May 2026
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by Andrace Deyampert, Victoria R Flournoy, Stephen O Agyemang

Inspected site

Inspection team

VRVictoria R Flournoy

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.115(a)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere